In high velocity wounds, such as those caused by explosive ordnance or explosive devices, significant tissue loss and tissue contamination is often experienced. Typical current field practice for war wounds and similar civilian trauma is to conduct meticulous debridement and serial irrigation of the wound, leaving the entire wound bed open, followed by application of high systemic concentrations of broad spectrum antibiotics and rapid evacuation of the patient to higher levels of care.
Furthermore, Iodoform gauze packing material has long been used to maintain wounds in an open status by packing the gauze into the wound bed. Such gauze packing material is the current standard, except for various exudate-absorbing or blood-absorbing wound dressing products, some of which include antimicrobial agents.
Another alternative wound packing material is manufactured by Biomet Europe under the trade name Septopal, and comprises chains of polymeric beads, positioned along a relatively stiff metal wire, the beads impregnated throughout with an antibiotic material. The distribution of antibiotic throughout Septopal-like beads usually results in incomplete and lengthy elution of the antibiotic, thereby causing unpredictable quantities of antibiotic to go unreleased. Also, such devices introduce the potential for prolonged low-level antibiotic elution from within the polymeric beads, and this prolonged low-level elution has the potential to promote development of drug-resistant bacteria.
Current medical literature also discusses the incorporation of antibiotic compositions throughout polymeric beads, and describes various methods of formation of such beads. For example, antibiotic composition can be mixed with polymethylmethacrylate and formed by hand or through a mold. Indeed, the Defense Medical Standardization Board (DMSB) treatment protocol for open wounds requires: “A minimum of 75 percent of all open wounds, with or without joint involvement, need to be treated with antibiotic beads. Pre-made antibiotic beads are not allowed by the FDA at this time, so will be made by the physician by using bone cement mixed with either a powder form of Vancomycin and/or Tobramycin.” The release of the antibiotic in such devices can be quite variable and unpredictable, and appears dependent on the antibiotic concentration within the bead, the cracks, channels and pores formed in the final product, the manufacturing source of the bead substance, etc. This can result in unpredictable elution profiles, resulting in over dosing or under dosing of antibiotic compositions. Over dosing can result in systematic levels of antibiotic being inadvertently, and potentially detrimentally, administered. Under dosing can result in insufficient application of the antibiotic to the wound site, thereby failing to optimally control the growth of pathogens.
Therefore, a need exists for improved methods and materials for treating high velocity wounds, including methods and materials that allow for easy application and removal of packing material, that can be added quickly and in a sterile manner to a wound, that aid in limiting infections of the wound, that allow controlled release of active agents, and that help in the prevention of drug-resistant microbes.